Systems Engineer I at Aditi Consulting
Columbia, MD 21046
About the Job
Note: Hybrid Opportunity
Qualifications
- 2-5 years of Solidworks® experience required creating part and drawings files, must understand and implement GD&T methodology.
- the ability to work a wide range of personalities in a team setting required
- Technical writing skills required
- Oral and written presentation skills required
- Experience with a variety of sensing and measurement technologies (thermocouples, photoelectric, vision, laser, etc.)
- Familiarity with a variety of manufacturing processes (machining, injection molding, additive manufacturing, sheet metal, welding, etc.)
- Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. medical device/pharma, aerospace, etc.)
- Experience interfacing with documentation control systems
- Bachelor’s Degree in engineering plus 3-5 years (of engineering experience in design and analysis within the medical device or another design-intensive industry
Responsibilities
- Participates as a team member on product packaging design teams and performs related design functions, including equipment design and troubleshooting, analysis, and technical writing
- Analyzes problems in design, process, and test development
- Recommend/implement solutions
- Prepares and presents oral and written project updates and technical discussions
- Writes and approves protocols and reports
- Manages testing outlined in protocols and test methods
- Manages/develops validation studies on equipment and processes in on-site packaging lab.
- Maintains a professional working relationship with internal and external customers and support staff
- Initiates new or revised documentation and tracks through appropriate approval cycles and implementation through PLM systems
- Understands and follows company procedures and regulatory requirements
- Develops and implements procedures/policy
Overview:
- Provides mid-level engineering activities of an organization's information systems.
- Typical Functions: Plans, designs, develops, evaluates, tests, and integrates an organization's systems infrastructure, including the implementation and design of hardware and software.
- Captures, understands, translates, and documents customer requirements.
- Defines system and product requirements; and generates mechanical, electrical, and software performance and reliability specifications and requirements.
- Creates and maintains programmatic and technical documentation to insure efficient planning and execution.
- Manages and documents system configurations and oversees all transitions into production.
- Performs troubleshooting and remediation, ensures successful project implementation, and performs post project end user support. 3-5 years of experience.
- Soft skills to include organizational, time management, action-oriented, and communication.
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.